Documents

Study Management Services

Data Safety Monitoring Board (DSMB)

Boston MedTech CRO assists the sponsor in the creation, recruitment of members and operation of the DSMB, a standard requirement for many clinical trials. Meetings of the DSMB are scheduled at pre-set intervals throughout the course of the study and after reaching pre-defined study milestones, reviewing the risks and benefits of procedures involving the tested device and providing the required assessment of the clinical risk, as needed to guide the continued progression of the trial and meet its ethical and clinical goals.

To ensure that the DSMB meets the regulatory requirements, Boston MedTech CRO assists with creation of the DSMB policies, establishment of its charter, identification of qualified board members, organization of meetings, oversight and coordination of communications and serving as the liaison between the DSMB and the sponsor.